ClinicalTrials.gov is a federally mandated database with a large and growing, number of required data fields. Organizations are required to report any study being conducted under FDA auspices. One of the mandated reporting fields is the date that the FDA receives notification of a clinical trial’s initiation, with less than 3% of the studies in the database missing that information.
ClinicalTrials.gov is a federally mandated database with a large and growing, number of required data fields. Organizations are required to report any study being conducted under FDA auspices. One of the mandated reporting fields is the date that the FDA receives notification of a clinical trial’s initiation, with less than 3% of the studies in the database missing that information.
The data show an initial spike in received studies by the FDA in 2008, when organizations conducting clinical trials were first required to report a study’s initiation date. Previous to that date, the reporting had been voluntary. Since 2008 the number of pharmaceutical company sponsored studies has most certainly not grown. If anything, there has been a slight decrease in recent years as many pharmaceutical companies look for ways to target more effectively their clinical trial efforts. This is most clearly seen with Phase II studies. To be sure, drug develop is a complex and uncertain undertaking. Moreover, conducting an individual clinical trial may be becoming ever more challenging. However, there is no verifiable database that indicates that pharmaceutical industry is increasing the number of Phase II and III clinical trials it conducts.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.